生物科技药业有限公司质量手册

QUALITY MANUALAuthorized By: Date:________________________________________________ __________________________ Thomas Oland, President________________________________________________ __________________________ Gregory Melsen, Chief Financial Officer________________________________________________ __________________________ Richard Krzyzek, VP Research________________________________________________ __________________________ Marcel Veronneau, VP Hematology Operations________________________________________________ __________________________ Shelley Falvey, Asst. Director, Quality and Regulatory AffairsQUALITY MANUAL SECTIONTITLE: CONTENTS Number: 540308 Revision: 11 Supersedes:540308.10 Section: 1.1Page: 1 of 1 Revision Date:4/2/09QUALITY MANUAL CONTENTS Section 11.1Page 1 Quality Manual Contents1.2Page 2 Quality Policy1.3Page 3 Company ProfileSection 2Quality System Requirements:2.1 Page 4, 5, 6 Management Responsibilities2.2 Page 7 Quality Audits2.3 Page 8 Personnel2.4 Page 9 Design Controls2.5 Page 10 Document Controls2.6 Page 11 Purchasing Controls2.7 Page 12 Identification and Traceability2.8 Page 13, 14 Production and Process Control2.9 Page 15 Acceptance Activities2.10 Page 16 Non-Conforming Product2.11 Page 17 Corrective and Preventive Action2.12 Page 18 Statistical Techniques2.13 Page 19 Labeling and Packaging Control2.14 Page 20 Material Handling, Storage and Distribution2.15 Page 21 RecordsPage: 1 of 1Revision Date: 4/2/2009R&D Systems Inc. Quality Policy:R&D Systems is committed to the highest level of quality in the manufacture, sale and support of our products. Product quality, compliance to all applicable regulatory requirements, continuous improvement and customer satisfaction shall underlie all of our efforts in development, manufacturing, advertising, sales, shipping and technical support.Definitions:Quality : the totality of features and characteristics that bear on the ability of a product to satisfy fitness for use, including safety and performance (§ 820.3 (s)).Quality system : the organizational structure, responsibilities, procedures, processes and resources for implementing quality management (§ 820.3 (v)).Assurance of quality and integrity are the responsibility of:1. the President, who has responsibility for creation of an atmosphere of high standards;2. the officers, directors, managers and supervisors, who are charged with development and implementation of quality systems; and3. each employee, who is responsible for the quality of his or her work and for suggesting improvements in quality.This Quality Manual is the top tier of our documentation system. It gives an overview of our Quality System. It is supported by corporate and division standard operating procedures (SOPs) which are the second tier of our Quality System documents and are listed in this Quality Manual. The third tier of the documentation system consists of manufacturing/testing documents, forms and specifications developed by each operating unit.Our policies are in conformance with the applicable requirements of the Code of FederalRegulations (21 CFR) Quality Systems Regulations for Medical Devices; ISO 13485 Standard: 2003, ISO 9001 Standard: 2008, the In Vitro Diagnostic Directive 98/79 EC and the Canadian Medical Device Regulations.Sections of the ISO 13485 Standard which do not apply to R&D Systems are as follows: Section 7.5.1.2.3 - Service activities (Reason: Applicable to equipment) Section 7.5.1.2.2 - Installation activities (Reason: Applicable to equipment) Section 7.5.1.3 -Section 7.5.2.2 - Particular requirements for sterile medical devices (Reason: No sterile products)Section 7.5.3.2.2Section 8.2.4.2 - Particular requirements for active implantable devices (Reason: No implantable devices)Related Procedures:540007 Canadian Medical Device License, Facility License and Quality SystemCertification540120 Required Standards Listing, Maintenance and Review}}Page: 1 of 1Revision Date: 4/2/2009R&D Systems was founded in 1976 in Minneapolis, MN. It is a wholly owned subsidiary of TECHNE Corporation (a holding company with no employees). The stock is traded publicly on NASDAQ’s National Market System under the “TECH” symbol. TECHNE has two operating subsidiaries: Research & Diagnostics Systems, Inc. (R&D Systems) and R&D Systems Europe Ltd. (R&D Europe).R&D Systems has two operating divisions: Biotechnology, which manufactures reagents primarily for the research market, and Hematology, which manufactures controls and calibrators for hematology analyzers. The Minneapolis manufacturing facility is certified to ISO 9001:2008 and ISO 13485:2003. The ISO Certificate numbers are FM547845 and FM547846, respectively. In July, 2005 R&D Systems purchased BiosPacific, which became a wholly owned subsidiary. BiosPacific is located in Emeryville, CA and consists of a sales force which provides raw materials for development of Immunoassay kits.R&D Systems Europe in Abingdon, England distributes biotechnology products and is the European Representative for the Biotech Division. They received ISO 9001: 2000 certification in June, 2007. Their ISO Certificate number is 951074360. EuroCell Diagnostics, Village de la Metairie Batiment B, 35131 Chartes de Bretagne is the European Representative for the Hematology Division.R&D Systems Europe has a sales subsidiary, R&D Systems GmBH, in Germany.R&D Systems established a wholly owned subsidiary in the People's Republic of China in May 2007. R&D Systems China Co. Ltd. opened its Warehouse and Distribution Center in Shanghai, China on October 1, 2007. R&D China provides products, marketing and technical support to our Chinese distributors.R&D Systems’ physical plant includes over 498,460 square feet of laboratory, manufacturing, shipping and office space as of December 1, 2008. Offices are in Minneapolis, MN, Abingdon, UK, Wiesbaden, Germany, Shanghai, China and Emeryville, CA with over 665 employees as of December 1, 2008.Section Title: Management Responsibilities Section: 2.1Page: 1 of 3Revision Date: 4/2/2009 Quality is the responsibility of each employee throughout our organization.Management is responsible for communicating our Quality Policy to all employees and for ensuring full understanding of, and commitment to, quality.∙The President has executive responsibility for the Quality System and is responsible for creating an atmosphere where quality is the highest priority.∙The Vice Presidents are responsible for overseeing the development, implementation and maintenance of the Quality System.∙The Asst. Director, Quality has been appointed as the Management Representative by the company president. The Management Representative has responsibility for ensuring that quality requirements are effectively established and maintained in accordance with theappropriate regulations and for reporting on the quality system to upper Management.∙The Asst. Director, Quality, Vice President of Operations (Hematology), and the Quality Assurance (QA) staff are responsible for ensuring that our quality system is fully maintained and implemented.∙Each director, manager and supervisor is responsible for assuring that Quality Systems are followed in his or her area.∙Each employee is responsible for the quality of his or her work.Two groups are dedicated exclusively to Quality:1. The Quality Assurance Department assists operating departments in the development ofquality systems and conducts periodic audits to assure that those systems are implemented faithfully and effectively. Quality Assurance has the responsibility to:∙identify and evaluate quality-related problems.∙recommend solutions to quality problems and verify that any problems have been resolved (corrective actions).∙initiate action to prevent the occurrence of quality problems (preventive actions).∙control non-conforming products until corrective action has been taken.∙set quality goals and objectives for the company and develop plans to meet those goals and objectives.∙report to Management on quality related issues.The Quality Assurance Department is responsible for quality systems, but implementation of these systems and quality per se is the responsibility of each director, manager, supervisor and employee.2. The Quality Control (QC) Departments inspect and test products at all stages of themanufacturing process, from raw materials to finished goods. Quality Control Managers have responsibility for product release against predetermined specifications. Due to the varied and highly technical nature of our products, QC functions are distributed throughout the corporation to ensure that testing and inspection are done expertly.The following charts describe the organizational and functional structure of the Company. While the structure and organization of the Quality function varies between the two divisions of R&D Systems, their goals are identical.Related Procedures:540009 Management Quality Systems Review ProcedureOrganizationAssurance541138 QualityQUALITY MANUALSection Title: Management ResponsibilitiesNumber: 540308Revision: 11Supersedes: 540308.10Section: 2.1Page: 2 of 3Revision Date: 4/2/2009 Quality Systems Flow ChartSection Title: Quality Audits Section: 2.2Page: 1 of 1Revision Date: 4/2/2009 Periodic audits assure adherence to our quality systems.Internal Quality System audits are performed by the Quality Assurance staff and by other trained personnel under the guidance of Quality Assurance. Results of audits are reported to the Assistant Director of Quality, the appropriate Vice President, the Company President, and the operating units involved. It is the responsibility of those units to develop corrective actions, to correct deficiencies and to present evidence of correction.Vendor audits are performed by Quality Assurance staff on an as needed basis.Other Quality System effectiveness checks are made by department managers and senior management, through periodic review of product complaints, non-conforming material tracking/trending and material review board meeting minutes.To ensure that the Quality System is effective and relevant, it is reviewed annually by the Senior Management Team, the Asst. Director of Quality, the Regulatory Affairs Specialist and other managers, as appropriate. The agenda for the meeting will be written by Quality Assurance based upon audit results and other outstanding issues related to Quality Systems and product quality. Minutes from the meetings shall be distributed to those present at the meeting as well as any designated attendees that are absent from the meeting. A copy of the agenda and meeting minutes will be maintained on file in Quality Assurance.Related Procedures:Corporate:540009 Management Quality Systems Review ProcedureMeetings541131 Quality540167 FDA Inspection Procedure540291 Internal Audit Procedure540335 Vendor Audit Procedure540552 Corrective and Preventive ActionBiotechnology:540135 Customer Feedback System, Biotech540259 Material Review Board Responsibility Procedure540550 Quality Assurance Auditing of GLP StudiesHematology:6016 Material Review Board Procedure8034 Technical Service Protocol/ComplaintsPage: 1 of 1Revision Date: 4/2/2009It is our policy to hire only qualified personnel and to assure that they are trained in all aspects of their jobs.Copies of job descriptions, job applications, resumes and annual performance reviews are kept on file in the Human Resources Department.The Company has a QSR/GMP training program (including the applicable regulations), conducted by Quality Assurance, which all employees are required to complete. Upon satisfactory completion of this training by an employee, a certificate of completion is given to the employee’s supervisor. Quality Assurance maintains a master log of all certificates of completion issued. Ongoing training, as necessary, assures personnel are familiar with applicable requirements.The Company has provided ISO 13485/CMDR and risk analysis training to Managers and Directors responsible for the manufacture and testing of our products. It is the responsibility of these trained employees to assure that all of their employees are familiar with the pertinent aspects of these regulations.Regulatory Affairs maintains a file of all pertinent Standards and assures that the latest revisions are available. When revisions are available, this is communicated to Quality Assurance and other pertinent personnel so that we can keep up-to-date on the latest regulations and standards. Each department maintains job-specific training records for its employees. Supervisors are responsible for job-specific training, for training on new or revised documents, for assuring that training is effective and for maintaining training records. Notification of document changes are issued as a trigger for training.Related procedures:540189 Personnel Training Procedure540816 Procedure for Generating Training Reports540120 Required Standards Listing, Maintenance and ReviewPage: 1 of 1Revision Date: 4/2/2009 We have different Design Controls for different types of products. In general, they cover the following points.1. Approval of the design goals (Design Input)2. Review of feasibility studies (Design Review)3. Approval of the product description (Design Output)4. Review of process development and preparation of manufacturing documents (DesignVerification Review)5. Review and approval of product validation (Final Design Review/Data Review)6. Transfer to manufacturingThe specific procedures for the different product lines are referenced below.Related Procedures:Biotechnology540045 Definition of Product Design Goals for Assay DevelopmentControls540325 Design540266 Procedural Elements in a Validation540215 Specific Immunoassay Validation Procedures (i.e., Linearity, Precision, etc.) 540217 through 540221, 540223, 540235 - 540238, 540288, 540337, 540409, 540729, 540804 and 541002Hematology6009 Procedural Elements in a Validation6009A Testing Protocol Request3421 Procedure for Developing Operational Procedures6015 Product Introduction/Product Improvement Procedure6015A Design Control and Transfer Worksheet6039 Product Development Request Form6026 Design Input6027 Design Output6040 Design Review ProcedureCorporate540819 Risk Analysis and ManagementPage: 1 of 1Revision Date: 4/2/2009To assure consistent quality, we use written, approved procedures for all operations. The Document Control and Quality Assurance departments or their designee(s) are responsible for controlling the issue, distribution, revision and archiving of these procedures.The documents that must be controlled include:The Quality Manual and Quality Systems SOPsDevice Master RecordsInternal Audit ReportsStandard Operating ProceduresManufacturing ProceduresTesting/Inspection ProceduresCalibration and Maintenance RecordsDevice History RecordsDesign Control RecordsFormsData from ATS StudiesEssential Requirements and Technical Document IndexesBiotechnology uses a formal Document Change Request (DCR) procedure for creating new documents and revising existing documents. It involves review and approval by multiple departments generally including a technical department, the affected department and the Quality Assurance department. The Hematology Division initiates formal Document Control in each Department. The Departmental Supervisor reviews a draft with assistance from designated individuals.Related Procedures:Corporate540643 Standard Operating Procedure (SOP) Review Procedure540578 Record Keeping GuidelinesDocumenta540146 Creating540748 MasterControl™ Electronic Documentation SystemFunctions540750 MasterControl™Biotechnology540205 Document Change Request ProcedureMaintenanceof Document Master Files&540382 Preparation540411 Master Document Replacement Procedure540532 Data Management: General Procedures & Definitions (ATS Lab) Hematology3007 New and Updated Procedure Protocols3008 Procedure Format6005 Document Organization (Document Control)3421 Procedure for Developing Operational Procedures6006 Updating the Device Master Record (DMR)6030 Format for "Product Description/Device Specifications" Documents6031 Format for "Product Type" DocumentsPage: 1 of 1Revision Date: 4/2/2009 Consistent quality of raw materials and contracted services is a key part of our quality system. Purchasing control covers the following areas:∙Specifications: Requirements for raw materials are stated in written specifications available to all personnel doing purchasing and receiving activities.∙Vendor Control: Qualified vendors are listed on each raw material specification. Document 540000, Vendor Qualification describes how to qualify new vendors in Biotechnology and Hematology including outsourced services and processes. Vendor performance is tracked and Vendors who do not perform well may be disqualified and replaced.∙Purchasing Control: The purchase order includes our part number and a request for a Certificate of Analysis where appropriate. All materials used in the manufacture of products are verified against the purchase order. Purchasing interacts with suppliers regarding non-conforming or damaged materials.∙Contract and Supply Agreements: Purchasing, Sales or Business Development is responsible to assure customer contracts and supply agreements are in place when required. Intellectual property contracts, customer contracts and supply agreements are managed by the Corporate Legal Department.Related Procedures:SystemsR&DProcedure,540687 PurchasingR&DSystems540192 ReceivingProcedure,Qualification540000 VendorProcedureAudit540335 VendorProcedure540876 QuarantinedProduct540805 Policy Regarding Contracts and Supply AgreementsRawMaterials Specifications (Biotech)640xxx Non-biologicalMaterial Specifications (Biotech)Raw645xxx Biological54xx, 55xx Biological Raw Material Specifications (Hematology)56xx, 57xx Non-biological Raw Materials Specifications (Hematology)Section Title: Identification and Traceability Section: 2.7Page: 1 of 1Revision Date: 4/2/2009The ability to trace a lot of product back to all raw materials used in its manufacture and to trace any lot of raw material to products it became part of is an essential feature of our Quality System.A part number and lot number (or receiving number) control all materials used to manufacture products. This provides complete traceability from receipt of raw materials through final shipment to the customer. In Biotechnology, Document Control is responsible for assigning part numbers. An MRP System (RenCS) is in place in the ELISA kit manufacturing area which is used to track inventory, assign job (lot) numbers and plan the production of the ELISA products. Lot numbers for all other products may be sequentially assigned from the Lot Number Database or are assigned at the time of bottling.The Hematology Director of Operations assigns final product lot numbers for Hematology products.Receiving departments are responsible for assigning receiving numbers to incoming raw materials.Related Procedures:540153 Part Number Assignment (Biotech)540523 Electronic Part Number Requisition Procedure540206 Lot Number Assignment (Biotech)540540 Receiving of Specimens for RDS-ATS Lab540831 RenCS, Add and Maintain Part Records8862 Assigning Final Product Lot Numbers (Hematology)6019 Identification and Traceability (Hematology)Page: 1 of 2Revision Date: 4/2/2009We design quality into our products. Areas of the manufacturing process that require control are identified during the development of a product and the effects of variables and appropriate limits are established.Process Control is accomplished through planning, written procedures, inspection, calibration, training, supervisory oversight and employee awareness. Changes to the manufacturing process, if required, are controlled, qualified and validated.∙Written procedures provide bills of materials, instructions for production, equipment required, working environment, filling and labeling instructions, record sheets, expiration dating, in-process testing, and acceptance criteria.∙Monitoring of product manufacture is accomplished through the use of Batch Records (Device History Records) containing the current revisions of the documents required for the manufacture of a product. Document Control assembles batch records for kit component manufacturing. Other manufacturing and Quality Control departments print official copies of their documents from MasterControl™. Operations, in Hematology, assembles the batch records. Quality Control verifies compliance through review and approval of completed batch records prior to final product release.∙The Specification Deviation Procedure handles deviations from the written procedures.∙All new inspection, measuring and test equipment is inspected and validated, when appropriate, against manufacturer’s specifications and identified with a permanent preventive maintenance number. Equipment is calibrated on a regular schedule. Improperly maintained or calibrated equipment will not be used. Records of calibration and maintenance aremaintained by the Facilities & Equipment Department. Quality Assurance audits equipment periodically, to ensure that calibration is proceeding according to schedule.∙The supervisor or lead personnel contributes to quality through training employees, assisting employees with new or specialized processes, interpreting instructions for andcommunicating process changes to employees.Related Procedures:ProcedureDeviation540126 Specification540142 Procedure for Documentation of Equipment Maintenance and/or Calibration 540310 Software Validation540133 Internal Notification Procedure: Receipt of New EquipmentPage: 2 of 2Revision Date: 4/2/2009 Biotechnology540781 Planning Guidelines, Immunoassay Manufacturing540834 RenCS, Recipe Authorization540833 RenCS, Add, Copy and Maintain a Process Specification540832 RenCS, Adding and Copying a Recipe540207 Product Finishing Label Control540072 Filling Operations Procedure540267 Preparation, Completion and Approval of Batch Records540278 Bottling Procedure for Cytokines and Antibodies Designated for Retail Sale 540256 Labeling Procedure for Cytokines and Antibodies Designated for Retail Sale 540134 Incoming Equipment Validation Procedure540503 Process Deviation Form, Dept 374540657 Process Deviation Form, Dept 375 and 394Hematology9090 Product Finishing Label Control9054 Bottling Procedure8812 Finished Device Inspection Procedure8813 Guideline for Determining Assay Ranges8006 Bottled Product Release8809 Assay Sheet Printing and Release6009A Testing Protocol Request6017 Product Type, Product Type Revision, Product Change NotificationSection Title: Acceptance Activities Section: 2.9Page: 1 of 1Revision Date: 4/2/2009 Acceptance/inspection activities are critical to the manufacture of quality products.∙Incoming materials are received in accordance with documented procedure(s).∙Deliveries are inspected against the purchase order for type, quantity and external transit damage. Additional inspection may include verification against Certificates of Analysis, in-house material specifications or incoming testing procedures.∙In-process testing is specified by the manufacturing and/or Quality Control procedures.Testing may include the recording of physical parameters such as pH and temperature, actual functionality testing and/or visual inspection.∙Final inspection and testing are completed before any product is released for sale. Quality Control signs the product release forms. Proteins and antibodies are released by the Director of Manufacturing. All documentation is reviewed and the product is physically inspected before release stickers are placed on the product and batch record.All inspections and testing must be supported by completed documentation. Release by exception must be documented and approved by the Material Review Board. Such approval must be documented.Related Procedures:540192 Receiving Procedure, R&D Systems540080 Raw Materials Departmental Receiving and Inspection Procedure540124 Inspection of Assembled Kits540143 Literature and Label Approval Procedure550449 Immunoassay Approval/Rejection Criteria540267 Preparation, Completion and Approval of Batch Records540526 Receiving of OEM Products540363 Releasing Retail Product540194 Certificate of Analysis Procedure541138 Quality Assurance Organization8812 Finished Device Inspection Procedure (Hematology)Section Title: Non-Conforming Product Section: 2.10Page: 1 of 1Revision Date: 4/2/2009Our quality system provides for the identification, documentation, evaluation, segregation, and disposition of non-conforming product.Quality Assurance administers the non-conforming materials system with the participation of the Material Review Board (MRB). Within departments producing research use only materials, appropriate technical personnel will review non-conforming material and make decisions concerning disposition of that material. Any employee with knowledge ofnon-conforming material may call for a Material Review Board meeting. Minornon-conformities may be released by Quality Control with adequate documentation. Disposition of major non-conformities lies with the MRB. QA is responsible for documenting the activities of the MRB. The Biotech MRB is composed of representatives from Quality, Manufacturing, and Development. Additional representatives from Product Support, Marketing, Technical Service or Sales may also participate as required. All corrective actions must be fully documented. Minutes from meetings of the MRB are published and maintained in MasterControl™.In Hematology, MRBs are documented using the Material Review Board (MRB) form. Minutes from meetings of the MRB are published and maintained in MasterControl™. A summary of MRBs is distributed quarterly to managers for review.All non-conforming material is clearly marked with Quarantine stickers or labeled appropriately. In addition, it is physically separated from conforming material until final disposition.A Specification Deviation is issued for any deviation in the manufacturing procedure even if it ultimately meets final release specifications. If a product is reworked, it must undergo all required inspections and tests as well as any additional inspection or testing required by the MRB. Reworked material must pass the same release criteria as the original product.Related Procedures:ProcedureDeviation540126 Specification540552 Corrective and Preventive Action540259 Material Review Board Responsibility ProcedureProcedure540265 Reprocessing540330 Procedure for Quarantine/Rejecting Approved Product (Biotech)3009 Adjustment/Replacement of a Finished Product (Hematology)6016 Material Review Board Procedure (Hematology)1012 Rework Procedure (Hematology)541214 Corrections, Removals and Recalls for IVD Products。

生物科技公司质量管理手册【最新资料，WORD文档，可编辑修改】目录一、颁布令二、企业概况三、任命书四、质量安全方针及安全目标五、组织机构及质量管理小组六、质量安全管理职责七、质量管理质量奖惩制度八、进货查验记录制度九、生产设备管理制度十、工艺管理制度十一、档案管理制度十二、从业人员培训制度十三、检测设备、计量器具管理制度十四、储存管理制度十五、人员卫生管理制度十六、化验室管理制度十七、产品防护控制制度十八、生产过程控制制度十九、产品出厂检验记录制度二十、不合品处理制度二十一、不符合情况管理办法二十二、从业人员健康检查制度二十三、食品安全事故处置制度二十四、不安全食品召回制度二十五、食品安全风险监测和信息收集制度二十六、食品生产安全自查管理制度一、颁布令本手册是根据《食品安全法》、《食品安全法实施条例》及《食品质量安全市场准入制度》《食品质量安全市场准入审查通则2010版》及《蔬菜制品生产许可证审查细则》、《糖果生产许可证审查细则》、《固体饮料生产许可证审查细则》、《配制酒生产许可证审查细则》对食品生产加工必备条件所作的有关规定及本公司的实际情况编制而成。

本手册适用于公司的玛咖深加工的生产加工过程。

本手册自2016年04月08日开始实施。

本汇编为本公司的质量管理基本制度，全公司各部门及全体员工要认真学习，所有人员都必须遵照执行，严格执行《质量管理手册》，保证产品质量安全。

不得有违反本手册的行为。

经理：和家权云南三迤兴生物科技有限公司2016年4月10日二、企业概况我工公司是专业的玛咖加工企业，创建于2016年，占地面积1500m2，建筑面积1200m2，年设计能力100吨。

固定资产投资为200万元，现有职工10人，专业技术人员3人，管理人员3人。

我公司将本着求实创新的精神，继续努力，为社会作出更大的贡献。

三、任命书一、质量负责人任命高政为公司质量负责人，全面负责质量安全工作, 具有以下质量职责和权限：A、在最高质量负责人领导下，具体负责本公司质量管理的日常领导工作。

【最新资料，WORD文档，可编辑】文件编号：____________________________________________________________________ ___________药业有限公司质量手册第一版审核：批准：日期：____________________________________________________________________ ___________地址：电话：传真：颁布令本公司依据ISO9001：2000《质量管理体系——要求》编制完成了《质量手册》第一版，现予以批准颁布实施。

本手册是公司质量管理体系法规性文件，是指导公司建立并实施质量管理体系的纲领和行动准则。

公司全体员工必须遵照执行。

总经理：年月日任命书为了贯彻执行ISO9001：2000《质量管理体系——要求》，加强对质量管理体系动作的领导，特任命为我公司的管理者代表。

管理者代表的职责是：1、确保质量管理体系的过程得到建立和保持；2、向最高管理者报告质量管理体系的业绩，包括改进的需求；3、在整个组织内促进顾客要求意识的形成；4、就质量管理体系有关事宜对外联络。

总经理：年月日1.0目录标题1.0 目录2.0 质量手册说明3.0 质量手册修改控制4.0 企业概况5.0 公司组织机构图6.0公司质量管理体系结构图7.0质量管理体系过程职责分配表8.0质量管理体系8.1文件控制程序8.2质量记录控制程序9.0管理职责9.1质量方针9.2管理策划控制程序9.3职责和权限9.4管理评审控制程序10.0资源管理10.1人力资源控制程序10.2设施和工作环境控制程序11.0产品实现11.1实现过程的策划程序11.2与客户有关的过程控制程序11.3设计和开发控制程序11.4采购控制程序11.5生产和服务运作控制程序11.6监控装置的控制程序12.0测量、分析和改进12.1客户满意程序测量程序12.2内部审核程序12.3过程和产品的测量和监控程序12.4不合格控制程序12.5数据分析控制程序12.6改进控制程序13.0 SMP、SOP文件目录2.0质量手册说明1、手册内容本手册系依据ISO9001：2000《质量管理体系—要求》和本公司的实际相结合编制而成，包括：⑴公司质量管理体系的范围，它包括了ISO9001：2000标准的全部要求；⑵质量管理标准和公司质量管理体系要求的所有程序文件；⑶对质量管理体系所包括的过程顺序和相互作用的表述。

某生物科技公司质量环境职业健康安全程序文件一、引言本文档旨在规范某生物科技公司的质量、环境以及职业健康安全方面的程序文件，并确保公司在运营过程中遵守相关法规和标准，以保障员工和环境的安全。

二、质量管理程序1. 质量方针1.1 公司的质量方针是确保产品符合相关法规和标准，满足客户需求，持续改进过程。

1.2 公司将不断提升员工的质量意识，培训员工掌握相关技能。

2. 质量目标2.1 每季度制定质量目标，并进行审查和调整。

2.2 定期进行内部质量审核，确保公司质量管理体系的有效运行。

三、环境管理程序1. 环境政策1.1 公司坚持环境保护理念，遵守相关环境法规和标准。

1.2 公司努力降低对环境的影响，推行绿色生产。

2. 环境目标2.1 每年制定环境目标，并进行监测和评估。

2.2 定期进行环境管理体系审核，确保环境政策的实施。

四、职业健康安全程序1. 安全政策1.1 公司致力于员工的职业健康安全，预防和减少职业伤害和职业疾病。

1.2 公司倡导安全第一的理念，提供必要的安全培训和设备。

2. 健康与安全目标2.1 每月制定健康与安全目标，并进行检查和落实。

2.2 定期进行职业健康安全审核，确保安全政策的贯彻执行。

五、术语与缩略语•QMS: 质量管理体系•EMS: 环境管理体系•OHSMS: 职业健康安全管理体系六、结语通过制定和执行本程序文件，某生物科技公司将不断提升质量、环境管理水平，并确保员工的职业健康安全。

公司将密切关注法规的变化，不断进行改进和调整，以适应市场需求和社会发展。

生物技术开发有限公司质量管理手册12020年4月19日质量管理手册(第一版)二○一二年三月一日批准二○一二年三月一日实施乌鲁木齐康福源生物技术开发有限公司发布目录目录............................................ 错误!未定义书签。

0.1<质量管理手册>批准公告........................ 错误!未定义书签。

0.2简介......................................... 错误!未定义书签。

0.3术语......................................... 错误!未定义书签。

1.0质量管理手册的管理 ........................... 错误!未定义书签。

1.1质量方针和质量目标 ........................... 错误!未定义书签。

1.2质量管理体系组织机构图 ....................... 错误!未定义书签。

2.0组织领导及职责权限分配 ....................... 错误!未定义书签。

3.0质量方针和质量目标的确定...................... 错误!未定义书签。

4.0质量管理体系文件和要素 ....................... 错误!未定义书签。

5.0 不合格管理办法.............................. 错误!未定义书签。

6.0环境卫生及废弃物处理管理...................... 错误!未定义书签。

6.1生产操作人员卫生管理制度...................... 错误!未定义书签。

7.0 生产厂区质量卫生管理制度..................... 错误!未定义书签。

8.0厂区要求..................................... 错误!未定义书签。

上海六合堂生物科技项城制药有限公司GMP文件
一目的建立说明书的质量依据及控制标准，以保证包材质量
二范围适用于说明书
三责任质量部全体人员对本规程实施负责
四内容
4.1.产品名称：说明书
4.2.产品代码：QC-W-002
4.4.贮藏条件：贮存在阴凉、通风干燥的库房，（属专人专柜加锁特殊管理）
4.5.有效期：以供应商生产日期起算，二年之内
4.6.产品规格：
4.7.包装形式：外有防潮纸包裹捆扎
4.8．标准依据：《药品说明书和标签管理规定》
4.9.取样操作规程：SOP-QC-020-00
4.10.检验操作规程：SOP-QC-W-002-00
4.11.适用品种：所有注册品种。

4.12.取样量：10张
5.附件/附表：无。

Q/DLYY.G.01-2017 质量手册发布日期2017－04－15 实施日期2017－04－20药业股份有限公司目次 (2)0.1颁布实施令 (4)0.2授权书 (5)0.3依据及参考文件 (6)0.4术语及定义 (7)0.5公司概况 (8)1.0 卫生质量方针和目标 (10)2.0 组织机构及其职责 (11)3.0 生产、质量管理人员的要求 (21)4.0 环境卫生的要求 (23)5.0 车间及设施卫生的要求 (25)6.0 原料、辅料卫生的要求 (27)7.0 生产、加工卫生的要求 (29)8.0 包装、储存、运输卫生的要求 (31)9.0 有毒有害物品的控制 (34)10.0 检验的要求 (36)11.0保证卫生质量体系有效运行的要求 (39)11.1不合格品的控制 (39)11.2 产品标识和可追溯性方法 (41)11.3 产品回收计划 (43)11.4 仪器设备维护 (45)11.5 文件控制 (47)11.6质量记录的控制 (50)11.7 内部质量审核 (52)11.8 管理评审 (54)附录A质量体系程序文件明细表 (55)附录B: 组织机构图 (57)附录C: 质量管理组织机构图 (58)第0.1章颁布实施令为了实施全面质量管理，保证出口产品质量，根据《中华人民共和国食品卫生法》、《出口食品生产企业卫生注册登记管理规定》等法律法规，结合公司的实际情况，编制本卫生质量手册。

卫生质量手册是阐述本公司质量方针（包括质量目标）以及卫生质量体系的建立和运行的法规性文件，是公司质量体系运行中应该长期遵循的法规和准则，全体员工必须认真贯彻执行。

本手册自批准发布实施之日起生效执行。

总经理：日期：第0.2章授权书为了加强卫生质量管理体系运作的领导，确保该体系持续有效运行、持续改进，特授权宋玉章同志为管理者代表。

管理者代表的职责是：1. 确保卫生质量管理体系建立、实施和保持。

2. 向最高管理者报告卫生质量管理体系的业绩和任何改进的需求。